Your Quality Management Data Template

Veeva Vault Quality
Your Quality Management Data Template

Your Quality Management Data Template

This template provides a clear roadmap for collecting the essential data points you need to analyze your Quality Management processes. It outlines the crucial attributes, key activities, and offers practical guidance for extracting this information from Veeva Vault Quality, ensuring a smooth start to your process mining journey.
  • Recommended attributes to collect
  • Key activities to track
  • Extraction guidance
New to event logs? Learn how to create a process mining event log.

Quality Management Attributes

These are the recommended data fields to include in your event log for a comprehensive analysis of your Quality Management process.
5 Required 8 Recommended 9 Optional
Name Description
Quality Event
QualityEvent
The unique identifier for a single quality event, such as a deviation, non-conformance, or CAPA.
Description

The Quality Event serves as the primary case identifier, linking all activities, investigations, and resolutions related to a specific quality issue. It acts as the central thread that connects the entire lifecycle of an incident from its initial report to its final closure.

In process mining, this attribute is crucial for reconstructing the end-to-end journey of each quality event. It allows for the analysis of process variations, cycle times, and compliance across different types of events, providing a comprehensive view of how individual quality incidents are managed, investigated, and resolved.

Why it matters

This is the essential Case ID that groups all related activities into a single process instance, making end-to-end analysis possible.

Where to get

This is the primary identifier for Quality Event records in Veeva Vault Quality, often referred to as 'Name' or a unique ID field on the Quality Event object.

Examples
QE-2023-00123CAPA-2023-00456DEV-2023-00789
Activity Name
ActivityName
The name of a specific task or step that occurred within the quality event lifecycle.
Description

This attribute describes a distinct business activity or event that happens during the management of a quality event. These are the steps in the process, such as 'Investigation Initiated' or 'Corrective Action Plan Approved'.

Analyzing the sequence and frequency of these activities is the core of process mining. It helps discover the actual process flow, identify bottlenecks between steps, and detect deviations from the standard operating procedure.

Why it matters

It defines the steps of the process, enabling the visualization and analysis of the process flow.

Where to get

This is typically derived from workflow task names, status changes, or audit trail entries within Veeva Vault Quality.

Examples
Initial Triage CompletedRoot Cause Analysis PerformedFinal Review And Closure
Event Time
EventTime
The timestamp indicating when a specific activity started or occurred.
Description

This attribute captures the precise date and time that an activity was executed. It provides the chronological context for all events within a case.

This timestamp is fundamental for all time-based process mining analyses. It is used to calculate cycle times, waiting times between activities, and durations of specific steps, which are essential for identifying delays and performance bottlenecks.

Why it matters

This timestamp is critical for ordering events chronologically and calculating all performance metrics like cycle time and waiting time.

Where to get

This corresponds to the creation date or completion date of tasks, or the timestamp of events in the audit trail of a Quality Event object.

Examples
2023-10-26T10:00:00Z2023-11-01T14:35:10Z2023-11-15T09:21:05Z
Last Data Update
LastDataUpdate
The timestamp of the last data refresh or extraction from the source system.
Description

This attribute indicates the freshness of the data being analyzed. It shows the date and time when the data was last extracted from Veeva Vault Quality and loaded into the process mining tool.

This information is critical for users to understand the timeliness of the analysis and to know if the dashboards reflect the most current state of operations. It is a key data governance attribute.

Why it matters

Informs users about the timeliness and relevance of the data, ensuring they understand how current the process analysis is.

Where to get

This timestamp is generated and added during the data extraction, transformation, and loading (ETL) process.

Examples
2024-05-20T08:00:00Z2024-05-21T08:00:00Z
Source System
SourceSystem
The system from which the quality management data was extracted.
Description

This attribute identifies the origin of the data, which in this case is Veeva Vault Quality. It helps in data governance and provides context, especially when data from multiple systems is combined.

In analysis, it's used for filtering and ensuring data lineage. Understanding the source system helps in interpreting the data correctly and troubleshooting any data quality issues.

Why it matters

Provides essential context about data origin, which is crucial for data governance, traceability, and multi-system analysis.

Where to get

This is a static value that should be added during the data transformation process to label all records from this source.

Examples
Veeva Vault Quality
Activity Duration
ActivityDuration
The processing time for a single activity.
Description

This metric measures the time spent actively working on a task. It is calculated as the difference between the EndTime and StartTime of an activity.

Analyzing activity duration helps pinpoint which specific steps in the process are most time-consuming. This differs from waiting time, as it reflects the actual work effort. It is a key metric for identifying inefficiencies within individual tasks and for resource capacity planning.

Why it matters

Measures the actual work time for tasks, helping to identify inefficient activities and opportunities for automation or simplification.

Where to get

This is a calculated metric, derived by subtracting the 'EventTime' (StartTime) from the 'EndTime' for each activity.

Examples
2 hours 30 minutes45 minutes8 hours 15 minutes
Assigned Department
AssignedDepartment
The department or functional area responsible for the quality event or activity.
Description

This attribute specifies the business unit or department, such as Quality Assurance, Manufacturing, or R&D, that is responsible for handling the quality event or a particular task. This is often derived from the assigned user's profile.

This dimension is critical for high-level performance analysis. It allows for comparing process efficiency and compliance across different parts of the organization, helping to pinpoint systemic issues within specific departments and supporting the 'Investigator Workload Distribution' dashboard.

Why it matters

Allows for filtering and comparing process performance across different business units, revealing departmental bottlenecks or best practices.

Where to get

This information is typically stored in user profile data linked to the 'Assigned Investigator' or can be a direct field on the Quality Event object itself.

Examples
Quality AssuranceManufacturing OperationsResearch & Development
Assigned Investigator
AssignedInvestigator
The user or resource assigned to perform an investigation or a specific task.
Description

This attribute identifies the person, role, or team responsible for executing a given activity within the quality event lifecycle. It can be the owner of the quality event itself or the assignee of a specific workflow task.

Analyzing this attribute helps in understanding workload distribution, resource performance, and identifying overburdened teams or individuals. It is essential for the 'Investigator Workload Distribution' dashboard and for optimizing resource allocation to improve efficiency.

Why it matters

Tracks who performs the work, enabling analysis of workload, resource efficiency, and identification of training needs.

Where to get

Found in the owner or assigned user fields on the Quality Event object or its related workflow task objects in Veeva Vault Quality.

Examples
Alice JohnsonBob WilliamsQA Investigation Team
End Time
EndTime
The timestamp indicating when an activity was completed.
Description

This attribute captures the date and time that a specific activity or task concluded. It is distinct from the StartTime (EventTime) and is essential for understanding the duration of individual steps in the process.

In process mining, the EndTime is used in conjunction with the StartTime to calculate the processing time of activities. This is fundamental for identifying which specific tasks are taking the longest, contributing to overall cycle time and potential delays.

Why it matters

Enables the calculation of activity processing times, which is crucial for identifying bottlenecks at the task level.

Where to get

This timestamp is typically available in the workflow history or audit trail data for a Quality Event, often as a 'completed date' or 'modified on' field for a specific task or status.

Examples
2023-10-26T11:30:00Z2023-11-01T18:00:10Z2023-11-15T09:45:00Z
Quality Event Status
QualityEventStatus
The current lifecycle state of the quality event.
Description

This attribute indicates the current status of the quality event, such as 'Open', 'In Investigation', 'Pending Approval', or 'Closed'. It provides a snapshot of where each case is in its lifecycle.

This is essential for the 'Quality Event Progress Overview' dashboard, enabling real-time monitoring of ongoing cases. It helps managers track progress, identify stalled events, and manage the overall workload effectively.

Why it matters

Provides a snapshot of the current state of a case, which is essential for monitoring ongoing work and identifying stalled events.

Where to get

This is a standard field on the Quality Event object in Veeva Vault Quality that reflects its position in the lifecycle.

Examples
In TriageIn InvestigationCAPA ProposedClosed
Quality Event Type
QualityEventType
The classification of the quality event, such as CAPA, Deviation, or Complaint.
Description

This attribute categorizes the quality event based on its nature. Different types of quality events often follow different process paths and have different compliance requirements and resolution timelines.

Analyzing by event type is fundamental to understanding process variations. It allows for comparing the performance and efficiency of handling deviations versus CAPAs, for example, and helps tailor improvement initiatives to specific process contexts.

Why it matters

Distinguishes between different kinds of quality processes, which often have unique workflows, SLAs, and compliance rules.

Where to get

This is a standard classification field on the Quality Event object in Veeva Vault Quality, often a picklist.

Examples
DeviationCorrective and Preventive Action (CAPA)Non-conformanceComplaint
Severity Level
SeverityLevel
The assessed severity or risk level of the quality event, such as high, medium, or low.
Description

This attribute classifies the quality event based on its potential impact on product quality, patient safety, or regulatory compliance. The severity often dictates the urgency and required depth of the investigation.

Analyzing by severity level is key to prioritizing improvement efforts. It helps understand if high-severity events take longer to resolve, follow different process paths, or have a higher rework rate, ensuring that the most critical issues receive the most attention.

Why it matters

Classifies events by impact, allowing for risk-based analysis and prioritization of process improvement efforts on high-risk areas.

Where to get

This is a standard classification field on the Quality Event object, often a picklist derived from a risk matrix.

Examples
HighMediumLow
Target Resolution Date
TargetResolutionDate
The planned or required date for the final closure of the quality event.
Description

This attribute defines the service level agreement (SLA) or target deadline for resolving a quality event. It is often calculated based on the event's creation date and its severity or type.

This date is the benchmark against which actual performance is measured. It is critical for the 'On-Time Resolution Performance' dashboard and the 'On-Time Resolution Rate' KPI, helping to identify whether events are being resolved in a timely manner and what factors contribute to delays.

Why it matters

Defines the SLA for case resolution, enabling the measurement of on-time performance and the analysis of delays.

Where to get

This is likely a date field on the Quality Event object, which may be manually entered or automatically calculated by the system.

Examples
2024-01-15T23:59:59Z2024-02-28T23:59:59Z2024-03-10T23:59:59Z
Approval Time
ApprovalTime
The time taken for a specific approval activity to be completed.
Description

This metric measures the duration of approval steps, such as 'Corrective Action Plan Approved'. It is calculated as the time from when an approval is requested to when it is granted or rejected.

This attribute is specifically designed to support the 'Approval Workflow Bottlenecks' dashboard and the 'Approval Workflow Cycle Time' KPI. By isolating the time spent waiting for approvals, it helps identify and address delays caused by slow decision-making or inefficient approval processes.

Why it matters

Pinpoints delays in critical decision-making steps, helping to streamline approval workflows and reduce overall cycle time.

Where to get

This metric is calculated by finding the time difference between the start and end of approval-related activities in the event log.

Examples
3 days 4 hours1 day 0 hours7 days 8 hours
Cycle Time
CycleTime
The total time elapsed from the creation of a quality event to its final closure.
Description

This metric represents the end-to-end duration for resolving a quality event. It is calculated as the time difference between the very first activity (e.g., 'Quality Event Created') and the very last activity (e.g., 'Final Review and Closure').

Cycle time is a primary key performance indicator for overall process efficiency. It is used in the 'Quality Event Resolution Time' dashboard to analyze trends, identify factors that lead to long resolution times, and set benchmarks for process improvement.

Why it matters

Measures end-to-end process efficiency, providing a critical KPI to track overall performance and the impact of improvement initiatives.

Where to get

This is a calculated metric. It is computed at the case level by subtracting the timestamp of the first event from the timestamp of the last event.

Examples
30 days 12 hours65 days 4 hours15 days 2 hours
Effectiveness Check Result
EffectivenessCheckResult
The outcome of the verification step to confirm if a corrective action was effective.
Description

This attribute records the result of the effectiveness check, which is performed after a corrective action has been implemented. The outcome is typically 'Effective' or 'Not Effective'.

This is a direct measure of the success of the CAPA process and is crucial for the 'CAPA Effectiveness & Recurrence Rate' dashboard and the 'CAPA Effectiveness Rate' KPI. It provides clear feedback on whether the implemented solutions are actually preventing the problem from happening again.

Why it matters

Directly measures the success of corrective actions, providing critical feedback for improving the problem-solving process.

Where to get

This would be a field, likely a picklist, on a CAPA Action or Effectiveness Check object related to the primary Quality Event.

Examples
EffectiveNot EffectivePending Verification
Is On Time Resolution
IsOnTimeResolution
A calculated flag indicating if the quality event was closed by its target date.
Description

This boolean attribute is derived by comparing the actual closure date of a quality event with its 'Target Resolution Date'. It provides a simple, binary outcome for on-time performance.

This flag is the foundation for the 'On-Time Resolution Performance' dashboard and the 'On-Time Resolution Rate' KPI. It allows for easy aggregation and filtering to understand what types of events, departments, or sites struggle to meet deadlines.

Why it matters

Provides a clear success or failure metric for meeting deadlines, simplifying performance analysis and reporting.

Where to get

Calculated by comparing the timestamp of the 'Final Review and Closure' activity with the 'TargetResolutionDate' attribute. Formula: Closure Time <= TargetResolutionDate.

Examples
truefalse
Is Recurrence
IsRecurrence
A flag indicating whether this quality event is a recurrence of a previously identified issue.
Description

This boolean attribute signals that a quality event is not a new, unique issue but a repeat of a problem that has occurred before. This is a critical indicator of the failure of previous corrective actions.

This flag is fundamental to the 'CAPA Effectiveness & Recurrence Rate' dashboard. Tracking recurrences provides direct feedback on the long-term success of the quality management system and helps identify systemic problems that are not being adequately addressed.

Why it matters

Highlights failures in corrective actions, enabling analysis of why problems are repeating and how to improve long-term solutions.

Where to get

This could be a checkbox field on the Quality Event object or a derived field based on links to previous, similar events.

Examples
truefalse
Is Rework
IsRework
A calculated flag that identifies activities or cases that represent rework.
Description

This attribute is a boolean flag indicating that a particular activity or sequence of activities represents rework, such as repeating an investigation or re-opening a closed CAPA. It is not a standard field but is calculated based on process flow patterns.

In process mining, this flag is used to quantify the amount of wasted effort and cost in the process. It is essential for the 'Rework Analysis' dashboard and the 'Quality Event Rework Rate' KPI, helping to pinpoint the causes of inefficiency and poor first-time quality.

Why it matters

Quantifies process inefficiency by flagging repeated work, which helps identify the root causes of quality issues and wasted effort.

Where to get

This attribute is not sourced directly. It is calculated during data transformation by detecting repeated activity names or loops in the process for a given case.

Examples
truefalse
Product
Product
The product or material associated with the quality event.
Description

This attribute links the quality event to a specific product, material, or batch. This connection is vital in regulated industries for traceability and impact analysis.

Analyzing quality events by product helps identify if certain products are more prone to issues, guiding product improvement or manufacturing process adjustments. It allows for filtering dashboards to see performance for specific product lines.

Why it matters

Links quality events to specific products, enabling analysis to identify product-specific issues and trends.

Where to get

This is typically a reference field on the Quality Event object that links to a Product or Material object in Veeva Vault.

Examples
Product A-100Product B-200Raw Material C-300
Root Cause
RootCause
The identified underlying cause of the quality event.
Description

This attribute contains the final conclusion of the root cause analysis (RCA) investigation. It categorizes the fundamental reason for the quality issue, such as equipment failure, human error, or procedural deficiency.

Analyzing root causes is essential for effective problem-solving. It helps identify recurring systemic issues that need to be addressed through corrective and preventive actions. This attribute directly supports the 'Root Cause Analysis Cycle Time' and 'CAPA Effectiveness' dashboards.

Why it matters

Categorizes the fundamental reasons for quality issues, enabling strategic analysis to prevent future recurrence.

Where to get

This is typically a text field or a picklist on the Quality Event object or a related Root Cause Analysis object.

Examples
Equipment MalfunctionProcedural ErrorInadequate TrainingMaterial Defect
Site
Site
The manufacturing site, plant, or location where the quality event occurred or was identified.
Description

This attribute specifies the physical location, such as a manufacturing plant or laboratory, associated with the quality event. It provides a geographical or organizational context for the issue.

This is a powerful dimension for comparative analysis, allowing management to compare process performance, issue types, and resolution times across different sites. It can help identify site-specific problems or share best practices from high-performing locations.

Why it matters

Provides a geographical or organizational dimension for analysis, helping to compare performance and identify site-specific issues.

Where to get

This is often a standard field on the Quality Event object, linking to a list of company sites or locations.

Examples
Site A - New JerseySite B - IrelandSite C - Switzerland
Required Recommended Optional

Quality Management Activities

These are the essential process steps and milestones to capture in your event log for accurate discovery and analysis of Quality Management.
7 Recommended 6 Optional
Activity Description
Corrective Action Implemented
Represents the completion of all tasks defined in the approved corrective action plan. This activity confirms that the necessary actions have been taken to address the root cause. This is captured when the CAPA record's status is updated to 'Implementation Complete'.
Why it matters

This is a major milestone that signifies the transition from planning to execution. The time between this and CAPA approval reveals the efficiency of the implementation phase.

Where to get

Inferred from a lifecycle state change on the associated CAPA object to a status like 'Implemented' or 'Pending Effectiveness Check'.

Capture

From the state change timestamp on the linked CAPA object.

Event type inferred
Corrective Action Plan Approved
Marks the formal approval of the proposed corrective action plan by relevant stakeholders, such as a quality review board. This is a critical gateway before any corrective actions can be implemented. It is captured when the CAPA plan record moves to an 'Approved' state.
Why it matters

This approval step is often a major bottleneck. Measuring the 'Approval Workflow Cycle Time' for this activity helps identify and address delays in the review process, accelerating overall resolution.

Where to get

Inferred from the timestamp of a lifecycle state change to 'Approved' on the associated CAPA Plan object. This event may be mirrored as a state change on the parent Quality Event.

Capture

From the state change timestamp on the linked CAPA Plan object.

Event type inferred
Effectiveness Of Action Verified
This activity confirms that the implemented corrective actions were successful in preventing a recurrence of the issue. A formal verification is completed and documented. It is captured when the CAPA or Quality Event status is updated to 'Effectiveness Verified'.
Why it matters

This is the final validation of the solution's success and is critical for calculating the 'CAPA Effectiveness Rate'. A failure at this stage often leads to rework, re-opening the investigation.

Where to get

Inferred from a lifecycle state change on the Quality Event or CAPA object to a status such as 'Verified' or 'Closed - Effective'.

Capture

From state change timestamp indicating successful verification.

Event type inferred
Final Review And Closure
Represents the last administrative review of the Quality Event record before it is officially closed. This step ensures all documentation is complete and all process steps were followed. This activity is the final step before the case is considered resolved.
Why it matters

This end activity is essential for calculating the total 'Quality Event Cycle Time'. It signifies the completion of all work, and its timestamp is compared against the 'Target Resolution Date' for performance measurement.

Where to get

Inferred from a lifecycle state change on the Quality Event object to 'Closed', 'Resolved', or a similar terminal state.

Capture

From the timestamp of the final state change to 'Closed'.

Event type inferred
Investigation Initiated
Marks the formal start of the investigation into the quality event's root cause. An investigator or team is typically assigned, and the event moves into an active investigative phase. This is captured when the Quality Event's lifecycle state changes to 'Under Investigation'.
Why it matters

This is a key milestone for measuring the 'Issue Identification-to-Investigation Time' KPI. Delays before this point indicate backlogs in assigning resources or starting critical analysis.

Where to get

Inferred from the timestamp when the Quality Event object's lifecycle state is updated to 'Under Investigation' or a similar status. The assignment of an investigator can also serve as a trigger.

Capture

Use the timestamp of the state change to 'Under Investigation'.

Event type inferred
Quality Event Created
This is the starting point of the process, representing the formal creation of a Quality Event record in Veeva. This activity is typically triggered when a new quality issue, non-conformance, or complaint is identified and logged into the system.
Why it matters

This activity marks the beginning of the case lifecycle, making it essential for calculating the total Quality Event Cycle Time and measuring the duration of initial process phases, such as the time to start an investigation.

Where to get

This is an explicit event captured from the creation timestamp of the Quality Event object in Veeva Vault. The audit trail for the object will show the exact creation date, time, and user.

Capture

Use the creation timestamp of the main Quality Event record.

Event type explicit
Root Cause Analysis Performed
Represents the completion of the root cause analysis (RCA) phase, where the underlying cause of the quality event has been identified. This is often logged when the investigator completes the RCA task or moves the event to a 'Pending CAPA' state.
Why it matters

This activity is crucial for measuring the 'Average Root Cause Analysis Time' KPI. Analyzing its duration helps identify bottlenecks in the analytical process and improve investigation quality.

Where to get

Typically inferred from a lifecycle state change on the Quality Event object, such as moving to 'RCA Complete' or 'Pending Action Plan'. It might also correspond to the completion of a specific workflow task.

Capture

From state change timestamp or completion of an RCA-related task.

Event type inferred
Corrective Action Plan Proposed
This activity occurs when a formal plan to correct the identified root cause is drafted and submitted for review. It often involves creating a related CAPA (Corrective and Preventive Action) record linked to the Quality Event. The event is captured when the CAPA record is created or the Quality Event status is updated.
Why it matters

Tracking this step helps analyze the time taken to move from analysis to solution design. It's a key input for understanding the 'Root Cause Analysis Cycle Time' from RCA completion to CAPA proposal.

Where to get

This can be inferred from a lifecycle state change on the Quality Event object to 'Pending CAPA Approval', or from the creation timestamp of a linked CAPA Plan record.

Capture

Use creation timestamp of a linked CAPA record or a state change.

Event type inferred
Effectiveness Check Initiated
Marks the beginning of the period where the effectiveness of the implemented corrective actions is monitored. This is not a point-in-time event but rather the start of a verification phase. It is captured when the Quality Event or CAPA record enters a 'Monitoring' or 'Pending Effectiveness Verification' state.
Why it matters

This activity initiates the final validation loop. The duration of the effectiveness check phase is important for understanding how long it takes to confirm a resolution's success.

Where to get

Inferred from a lifecycle state change on the Quality Event or CAPA object to a status like 'Under Effectiveness Review'.

Capture

From state change timestamp to a monitoring-related state.

Event type inferred
Initial Triage Completed
Represents the completion of the initial review and assessment of the quality event. During this stage, basic information is gathered and verified to determine the event's validity and immediate impact. This is often captured when the record's status changes from 'New' to 'Under Assessment' or a similar state.
Why it matters

Analyzing the time spent in triage helps identify delays in the initial handling of quality events. It provides insights into workload and resource allocation at the very beginning of the process.

Where to get

Inferred from the timestamp when the Quality Event object's lifecycle state is updated to reflect that triage is complete, for example, moving from 'New' to 'In Assessment' or 'Triaged'.

Capture

From state change timestamp on the Quality Event object.

Event type inferred
Issue Categorized And Prioritized
This activity marks the point where the quality event has been formally categorized by type, severity level, and priority. This is a critical step that determines the subsequent investigation path and timeline. It's typically captured by a status change indicating the completion of this classification.
Why it matters

This event is crucial for segmenting process analysis by event severity or type. It helps understand if high-priority issues are processed faster than low-priority ones and ensures resources are allocated effectively.

Where to get

Inferred from a lifecycle state change on the Quality Event object, such as moving to a state like 'Categorized' or 'Pending Investigation'. It can also be inferred from the timestamp when key classification fields are populated.

Capture

Inferred from a state change or population of fields like 'Severity' and 'Priority'.

Event type inferred
Preventive Action Identified
This activity occurs when a preventive action is identified to address potential future recurrences, often as a result of the investigation. It is captured by the creation of a Preventive Action (PA) record linked to the quality event.
Why it matters

While not part of every case, tracking this activity helps understand how proactive the quality process is. It provides insights into the organization's focus on long-term prevention versus immediate correction.

Where to get

Inferred from the creation timestamp of a linked Preventive Action record within Veeva Vault.

Capture

Use creation timestamp of a linked Preventive Action record.

Event type inferred
Stakeholders Notified Of Resolution
This activity represents the communication sent to relevant stakeholders informing them of the quality event's resolution. This might be an automated email notification triggered by the final closure step or a manually logged communication task.
Why it matters

Timely communication is key to stakeholder satisfaction and transparency. This activity allows for measuring the 'Stakeholder Notification Lag Time' KPI, highlighting delays in communication.

Where to get

This may be an explicit event if Veeva Vault sends automated notifications that are logged. Alternatively, it could be inferred from the completion of a manual 'Notify Stakeholders' workflow task.

Capture

From system notification logs or the completion timestamp of a communication task.

Event type explicit
Recommended Optional

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